28
Participants
Start Date
May 21, 2025
Primary Completion Date
January 1, 2028
Study Completion Date
January 1, 2029
Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone
"Subjects will receive a course of inotuzumab ozogamicin administered by central venous catheter over 60 minutes on days 1, 8, and 15.~Venetoclax (by mouth or NG) and dexamethasone (by mouth, NG, or IV) are given daily per assigned dose level. Venetoclax and dexamethasone are started 2 days prior to inotuzumab to limit risk of tumor lysis syndrome with a two-day venetoclax ramp up in cycle 1. On days 1 and 8, venetoclax administration should be scheduled for 4 hours after the beginning of inotuzumab ozogamicin administration. If the patient is not able to ingest venetoclax at the scheduled time, it may still be given later in the day, but efforts should be made to administer the venetoclax within 2 hours of the scheduled time whenever possible."
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
OTHER